Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

D6N-acetate was evaluated in a bacterial mutagenicity assay over a range of concentrations using four strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and two strains of Eschericia coli (WP2P and WP2P uvrA) in the presence and absence of a rat liver-derived metabolic activiation system (S9-mix).

 

In two separate experiments, the test substance did not induce any significant, reproducible increases in the observed numbers of revertant colonies in any of the tester strains used, either in the presence or absence of S9-mix. 

 

The sensitivity of the test system, and the metabolic activity of the S9-mix, were clearly demonstrated by the increases in the numbers of revertant colonies induced by positive control substances. 

 

It is concluded that, under the conditions of this assay, D6N-acetate gave a negative, ie non-mutagenic response in S. typhimurium strains TA1535, TA1537, TA98, and TA100 and E.coli strains WP2P and WP2P uvrA in both the presence and absence of S9-mix.

By read across, it is also concluded that delta-6-nandrolone gives a negative, non-mutagenic response under the conditions of the test.


Short description of key information:
Based on read-across form a similar substance, D6N is not genotoxic in both the presence and absence of S9-mix.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Under the conditions of the available test, D6N-acetate gave a negative, (ie non-mutagenic) response in S. typhimurium strains TA1535, TA1537, TA98, and TA100 and E.coli strains WP2P and WP2P uvrA in both the presence and absence of S9-mix. Therefore, based on this data for similar substance, D6N is not classified as genotoxic.